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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neuropathy (1983)
Event Date 06/01/2015
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for analysis as they were implanted in the patients. Based on the reported information, there is no evidence suggesting that the devices were defective. All patients presented with cranial neuropathy before pipeline treatment; the cause of continued neuropathy in the patients after pipeline treatment could not be conclusively determined from the provided information. Brown, b. (2015). Oral presentations 2014 aans annual scientific meeting san francisco, california ¿ april 5¿9, 2014 published online june 1, 2015; doi: 10. 3171/2015. 6. Jns. Aans2014 abstracts. Journal of neurosurgery, 122(6), a1552. Doi:10. 3171/2015. 6. Jns. Aans2014 abstracts. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from literature review of patient outcomes after pipeline treatment. The purpose of this article was to compare endovascular flow diversion with microsurgical decompression in restoring function in cranial neuropathy. The medical records of 43 patients with 43 treated aneurysms that fit the criteria were retrospectively reviewed. The patients had presented with cranial neuropathy (2, 3, 4, and 6th cranial nerve) due to cerebral aneurysms and had been treated with the pipeline embolization device. The aneurysms were located the internal carotid artery (ica) (cavernous or distal to cavernous segment). There were 40 females, 3 males, mean age of 64. 5years. It was reported that the 30-day morbidity was 14%. It was also reported that the rate of cranial nerve improvement after pipeline was 39. 5%, 69. 2%, and 81. 25% at 3, 6, and 12 months, respectively.
 
Manufacturer Narrative
Event description - additional information. Initial report - additional information. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional information from review of an article by the same authors. The purpose of the article was to determine whether flow diversion with pipeline embolization device (ped) can approximate microsurgical decompression in restoring function after cranial neuropathy following carotid artery aneurysms. The authors reviewed 45 patients with 45 aneurysms in the proximal intracranial internal carotid artery (ica) treated with ped. Of the patients, 42 were female and 3 were male; mean age was 64. 7 years. All 45 patients presented with symptoms of cranial neuropathy. The 30-day morbidity was 17. 8% including 3 ischemic strokes, 2 hemorrhagic strokes, 1 gastrointestinal bleed, 1 myocardial infarction, and 1 new-onset cranial neuropathy. There was 1 ischemic stroke with lasting morbidity, making the 30-day rate of major stroke or death 2. 2%. At the last follow-up, cranial nerve deficits resolved in 19 patients, improved in 11, were unchanged in 14, and worsened in 1. Brown, b. L. Et al. (2016). The fate of cranial neuropathy after flow diversion for carotid aneurysms. Journal of neurosurgery, 124(4), 1107-1113. Doi:10. 3171/2015. 4. Jns142790.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key5762381
MDR Text Key48569312
Report Number2029214-2016-00481
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2016 Patient Sequence Number: 1
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